Catalog Number

88685

Brand Name

Monaghan

Version/Model Number

Kit, Educational, MMC Z STAT™ aVHC

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

-

Product Code Name

-

Public Device Record Key

19918fa6-7e1f-44a4-b302-221cbfc3acf2

Public Version Date

September 09, 2021

Public Version Number

2

DI Record Publish Date

October 12, 2018

Package DI Number

50604351886853

Quantity per Package

1

Contains DI Package

00604351886858

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Single